A. Field of the Invention
The present invention relates to medical devices, components, and methods for use thereof, such as bone drills, bone drill assemblies, bone impact drills, bone cavity creation/enlargement devices, guide forceps, and fluid transfer device, especially those for treating vertebral body and sacral fractures, as well as lytic (destructive) tumor deposits in bone, for use in bone biopsies/bone infusions, for procedures requiring bone access and for use in medical procedures requiring a drill driven screwdriver or similar tools especially when there is a need for an off-angle, largely radiolucent bone access device having radiation protection for the operator designed to be used with X-ray (fluoroscopic) guidance.
B. Background Information
Throughout the years and most recently in particular, various instruments have been developed for use in and for particular medical procedures and/or techniques requiring bone access. In some bone access procedures, it is necessary to create one or more holes in a bone or bone sections or to bore through the bone. Medical instruments known as bone drills have been developed for creating such holes and bores. Other instruments such as catheters, needles, guide needles, curettes and the like may then be introduced into the hole. On occasion, a cavity needs to be created or enlarged to facilitate treatment of a bone lesion.
Examples of medical procedures or techniques that require drilling into bone (and thus the use of a bone drill) often require creating a cavity or enlarging a cavity in the bone including vertebroplasty and/or vertebral augmentation procedures, sacroplasty, osteoplasty and bone biopsies/infusions. Other medical procedures require the use of drill-driven screwdrivers or similar tools which may need to be used with X-ray (fluoroscopic) guidance.
Vertebroplasty is a procedure for treating vertebral body (spinal) compression fractures. Sacroplasty is a procedure for treating sacral fractures. Osteoplasty is a procedure for treating painful lytic (destructive) tumor deposits in bone. Osteoporosis is the most common cause for vertebral compression fractures and sacral fractures but tumors involving the spine such as multiple myeloma and metastatic disease can also cause these fractures. A vertebral body compression fracture (VCF) is a fracture involving the vertebral body which causes the vertebral body to be compressed or to collapse. This can lead to shortening and tilting of the spinal column with a forward curvature. This forward curvature can lead to pulmonary and gastrointestinal complications. These fractures are extremely painful and debilitating with many of these patients needing wheelchairs for less painful ambulation; many of these patients are bed-ridden. Vertebroplasty is designed to stabilize VCFs and relieve pain. Vertebral height restoration and deformity reduction are also desired.
In vertebral augmentation and vertebroplasty, access needles are manually pushed or hammered into the fractured vertebral body using fluoroscopic (X-ray) guidance. Various instruments such as a curette may then be inserted through the access needles or tubes. At that point in vertebroplasty, an orthopedic bone filler/cement (e.g. PMMA) is instilled into the fractured bone. However, in vertebral augmentation, before the bone cement is instilled, balloon catheters are inserted through the access needles or tubes into the fractured vertebral body and inflated in an attempt to restore the compressed/collapsed vertebral body to its original height and also to create a cavity in the fractured bone. Following the balloon dilation, the balloons are removed and thicker bone cement is instilled into the fractured vertebral body through the access needles or tubes. The cement hardens quickly for both procedures, providing strength and stability to the vertebra. The progress of both procedures is continually monitored in real time with fluoroscopic (X-ray) guidance.
In sacroplasty, access needles are manually pushed or hammered into the fractured sacrum using fluoroscopic (X-ray) or computed tomographic (CT) guidance. Various instruments such as curettes or balloons may then be inserted through the access needles. An orthopedic bone filler/cement (e.g. PMMA) is then instilled through the access needles/tubes into the fractured sacrum. This has been found to provide pain relief and stability. Procedural progress is continually monitored with CT and/or fluoroscopic guidance.
In osteoplasty, access needles are manually pushed or hammered into the lytic (destructive) bone tumor deposit using fluoroscopic (X-ray) or computed tomographic (CT) guidance. Various instruments such as curettes, balloons, or radiofrequency (RF) probes may be inserted through the access needles. An orthopedic bone filler/cement (e.g.) PMMA is then instilled through the access needles/tubes into the lytic deposit. This has been found to provide pain relief and stability. Procedural progress is continually monitored with CT and/or fluoroscopic guidance.
In bone biopsies, needles are manually pushed or hammered into the bone in order to obtain a specimen. In bone infusions, needles are manually pushed or hammered into the bone in order to achieve bone access.
It has been recognized that it is desirable for a bone drill/impact drill to place the access needles in the targeted bone in a single step using fluoroscopic (X-ray) or CT guidance. It has also been recognized that it is desirable for this bone drill/impact drill to have a guide tube or access needle/conduit in conjunction with a drill bit, the guide tube surrounding the drill bit. The guide tube/access needle may then be used as a conduit into the targeted bone. Placing the access sheath/conduit/tube/needle in a single step increases speed and accuracy of access placement thus improving safety and decreasing radiation exposure to the operator. This drill/impact drill can also be used with various bits (such as a screwdriver) for various medical procedures. However, existing drills suffer from various design defects that make them unsuitable to be used with fluoroscopic (X-ray) or computed tomographic (CT) guidance for these procedures. It is often difficult to place needles or access devices into bone by manually pushing or hammering; also the currently used devices result in excessive radiation exposure to the operator (particularly the hands). Also, currently available bone curettes do not reliably create a cavity in the accessed bone and also result in excessive radiation exposure to the operator (particularly the hands).
It is thus evident from the above that there is a need for an improved bone drill and/or impact drill and related methods of use. It is evident that there is a need for improved drill bits to be used for these applications. It is evident from the above that there is a need for improved cavity creation/enlargement in the targeted bone. It is also evident that there is a need for operator radiation protection when using these devices. It is further evident that there is a need for a guide forceps to be used with these devices. It is also evident that there is a need for a fluid-transfer device to be used with these devices.